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FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes
23 October 2017 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon ® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 23, 2017 Category: Drugs & Pharmacology Source Type: news

Shingrix (zoster vaccine recombinant, adjuvanted) Approved in the U.S. for Prevention of Shingles
London UK 20 October 2017 -- GlaxoSmithKline plc [LSE/NYSE: GSK] today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
October 18, 2017 -- The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 18, 2017 Category: Drugs & Pharmacology Source Type: news

Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Horsham, Pa., October 13, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 13, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lyrica CR (pregabalin) Extended-Release Tablets for Neuropathic Pain Conditions
October 12, 2017 - Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (FDA) has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 12, 2017 Category: Drugs & Pharmacology Source Type: news

Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain
BURLINGTON, Mass., Oct. 06, 2017 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta (triamcinolone acetonide extended-release injectable suspension), the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 6, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Botox Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines
DUBLIN, Oct. 3, 2017 /PRNewswire/ -- Today Allergan plc (NYSE: AGN) announced the FDA approval of Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy
Santa Ana, California October 3, 2017 -- McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration ’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin
PLAINSBORO, N.J., Sept. 29, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 29, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
September 28, 2017 -- The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Verzeniov (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
September 28, 2017 -- The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
KENILWORTH, N.J.--(BUSINESS WIRE) September 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company ’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 22, 2017 Category: Drugs & Pharmacology Source Type: news

Bristol-Myers Squibb ’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
PRINCETON, N.J.--(BUSINESS WIRE) September 22, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 22, 2017 Category: Drugs & Pharmacology Source Type: news

BioCryst's Rapivab (peramivir injection) Receives FDA Approval for a Pediatric Indication
RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2017 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 21, 2017 Category: Drugs & Pharmacology Source Type: news

Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
YARDLEY, Pa.--(BUSINESS WIRE)-- September 18, 2017 -- Optinose, an ENT / Allergy specialty pharmaceutical company, announced today that the U.S. Food& Drug Administration (FDA) approved the Company ’s New Drug Application (NDA) for Xhance... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 19, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD
London UK – 18 September 2017 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved once-daily, single inhaler triple therapy fluticasone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Symbiomix Therapeutics ’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
NEWARK, N.J.--(BUSINESS WIRE) September 18, 2017 --Symbiomix Therapeutics today announced the U.S. Food and Drug Administration (FDA) has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Indication for Ipsen ’s Somatuline Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
Paris (France) September 18, 2017 -- Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline Depot (lanreotide) Injection 120 mg for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD
DALLAS and FORT WORTH, Texas, Sept. 15, 2017 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release products using its proprietary... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 15, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults
Atlanta, Georgia (U.S.)& Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Briviact (brivaracetam) CV as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 15, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin
September 14, 2017 -- The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma
September 14, 2017 -- The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

CSL Behring Announces FDA Approval of Privigen [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults
KING OF PRUSSIA, Pa. — 14 September 2017 -- Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion ’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
MARLBOROUGH, Mass.--(BUSINESS WIRE)--September 14, 2017 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the indication for its... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

Seqirus Receives FDA Approval of Afluria Quadrivalent (Influenza Vaccine) for People Five Years of Age and Older in the U.S.
Cambridge, Mass — September 14, 2017 -- Seqirus announced today that the U.S. Food and Drug Administration (FDA) has approved Afluria Quadrivalent (Influenza Vaccine) for use in people five years of age and older, extending the company's broad... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2017 Category: Drugs & Pharmacology Source Type: news

Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension
SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 6, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Guerbet's Dotarem (gadoterate meglumine) for Pediatric Patients Younger Than Two Years
PRINCETON, N.J., Sept. 5, 2017 /PRNewswire/ -- Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced today that the US Food and Drug Administration (FDA) has approved Dotarem... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 5, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia
September 1, 2017 -- The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
South San Francisco, CA -- August 30, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra ® (tocilizumab) intravenous injection for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 31, 2017 Category: Drugs & Pharmacology Source Type: news

Teva Announces FDA Approval of Austedo (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults
JERUSALEM--(BUSINESS WIRE) August 30, 2017 --Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) tablets for the treatment of tardive... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
August 30, 2017 -- The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vabomere (meropenem and vaborbactam) for Complicated Urinary Tract Infections
August 29, 2017 -- The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 29, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Benznidazole as First U.S. Treatment for Chagas Disease
August 29, 2017 -- The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 29, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 29, 2017 Category: Drugs & Pharmacology Source Type: news

Faslodex (fulvestrant) Receives FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer
August 28, 2017 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 28, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves KedRAB [rabies immune globulin (Human)] for Post-Exposure Prophylaxis of Rabies Infection
Fort Lee, NJ/Rehovot, Israel – August 25, 2017 - Kedrion Biopharma and Kamada Ltd. (NASDAQ and TASE: KMDA), two leading human-derived protein therapeutics companies, today announced that KedRAB™ [rabies immune globulin (Human)] has received U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 25, 2017 Category: Drugs & Pharmacology Source Type: news

Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients
PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 25, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
EMERYVILLE, Calif., Aug. 24, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the U.S. Food and Drug Administration (FDA) has approved Gocovri (amantadine) extended release capsules (previously ADS-5102) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 21, 2017-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced Duzallo was approved by the U.S. Food and Drug Administration (FDA) as a once-daily oral treatment for hyperuricemia associated with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tablet Formulation of Lynparza (olaparib) for Maintenance Treatment of Ovarian Cancer
August 17, 2017 -- AstraZeneca and Merck& Co., Inc., (Merck: known as MSD outside the U.S. and Canada) today announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
August 17, 2017 -- The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2017 Category: Drugs & Pharmacology Source Type: news

CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension
Farmville, NC. August 7, 2017 – CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir (Spironolactone Oral Suspension, 25 mg/5mL), the first... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
August 6, 2017 -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
August 3, 2017 -- The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
August 3, 2017 -- The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
August 2, 2017 -- The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 2, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 1, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa ® (sofosbuvir 400mg/velpatasvir 100mg), the first... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
August 1, 2017 -- The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 1, 2017 Category: Drugs & Pharmacology Source Type: news

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
PRINCETON, N.J.--(BUSINESS WIRE) August 1, 2017 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 1, 2017 Category: Drugs & Pharmacology Source Type: news

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
Valby, Denmark and Tokyo, Japan, 28 July 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced Abilify Maintena ® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2017 Category: Drugs & Pharmacology Source Type: news